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Biocad trastuzumab

Trastuzumab biosimilar developed by Biocad, development code BCD-022. Reference product Herceptin.

Brands by market: Brand not published by CDSCO (India, import) · Commercial partner or holder: Biocad India (import) · Company profile
FDANot listed
EMANot listed
MHRANot listed
PMDANot listed
HCNot listed
CDSCOApr 2018permitted
EDENot listed
Approved or registered in 1 of 7 markets
Connections
TrastuzumabmoleculeBiocaddeveloper1 of 7markets1trial behind it2other products, same developer6rival developers in its markets

About Biocad trastuzumab

Biocad, the Russian biotechnology company, holds an Indian import permission for its trastuzumab from 2018, covering breast cancer before and after surgery and in advanced disease. Biocad also imports its rituximab and infliximab into India, making it the only foreign biosimilar developer with a broad Indian presence outside the seven regulators' home markets.

Status by market

FDA

United States

Not listed by FDA.

EMA

European Union

Not listed by EMA.

MHRA

United Kingdom

Not listed by MHRA.

PMDA

Japan

Not listed by PMDA.

HC

Canada

Not listed by HC.

CDSCO

India

Central Drugs Standard Control OrganisationApproved
Brand
Not published by CDSCO (INN only)
Holder or applicant
Biocad India Pvt Ltd
Pathway
Import and marketing permission
Approved
Apr 2018
Application or permission
Import permission
Indications as licensed
Neoadjuvant, adjuvant and metastatic HER2-positive breast cancer
Presentations
150 mg single-use and 440 mg multi-use vials
Source
S013 (CDSCO) · checked Sep 2026
EDE

United Arab Emirates

Not listed by EDE.

Trials behind this product

Comparative trials on ClinicalTrials.gov matched to Biocad trastuzumab by development code, brand or developer. Registry data, sponsor-entered.

CandidateDeveloper or sponsorReference productPhaseDesignRegistry statusStartedPrimary completionRegistry record
BCD-022BiocadHerceptinPhase 3Comparative efficacyCompletedOct 2012Mar 2015NCT01764022

Other developers in the same markets

Where Biocad trastuzumab holds an approval, these are the other trastuzumab biosimilars approved in that market.

MarketRivalsDevelopers (product)
CDSCO6Biocon Biologics (Ogivri / CANMAb), CuraTeQ Biologics (Dazublys / CuraTeQ trastuzumab), Dr. Reddy's Laboratories (Dr. Reddy's trastuzumab), Intas Pharmaceuticals (Intas trastuzumab), Reliance Life Sciences (Reliance Life Sciences trastuzumab), Zydus Lifesciences (Zydus trastuzumab)

Same developer, other molecules

Other biosimilars in the Atlas developed by Biocad: Biocad infliximab, Biocad rituximab.

Chronology

Sources

All trastuzumab biosimilars

Planning trastuzumab biosimilar development?

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Data current to September 2026.